When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to diflunisal, aspirin, or other pain and arthritis medicines such as ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, Motrin®, or Vioxx®. The reaction may have included wheezing or trouble breathing, hives, rash, or swelling in your face. You should not use this medicine if you have a stomach ulcer, a bleeding disorder, or if you are pregnant or are breast feeding. Do not take this medicine if you have advanced kidney disease. This medicine should not be used in children less than 12 years of age. Do not use this medicine right before or right after having coronary artery bypass graft (CABG), a type of heart surgery.

How to Use This Medicine:
Tablet

• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Use this medicine for the shortest time possible and in the smallest dose possible. This will help lower the risk of side effects.
• Swallow the tablet whole with a full glass of water. Do not chew or crush it.
• It is best to take this medicine with food or milk so it does not upset your stomach.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, a blood thinner such as warfarin (Coumadin®), or a steroid such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®. Tell your doctor if you are using methotrexate (Rheumatrex®, Trexall®), or a diuretic ("water pill") such as furosemide, hydrochlorothiazide (HCTZ), torsemide, Demadex®, or Lasix®.
• Make sure your doctor knows if you are using acetaminophen (Tylenol®), antacids (Maalox®, Mylanta®), cyclosporine (Neoral®, Sandimmune®), or lithium (Eskalith®, Lithobid®). Tell your doctor if you are using a blood pressure medicine such as candesartan, enalapril, lisinopril, losartan, olmesartan, valsartan, Accupril®, Atacand®, Cozaar®, Diovan®, Hyzaar®, Lotrel®, or Zestril®.
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other NSAIDs are aspirin, diclofenac, ibuprofen, indomethacin, naproxen, sulindac, Advil®, Aleve®, Celebrex®, Motrin®, or Voltaren®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have a history of ulcers or other stomach problems. Tell your doctor if you have bleeding problems, liver disease, or kidney disease. Make sure your doctor knows if you have asthma, high blood pressure, congestive heart failure (CHF), or other heart or circulation problems.
• This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
• This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner).
• This medicine can cause a rare but serious illness called Reye's syndrome. It occurs mostly in children and teenagers, but can affect someone at any age. Do not give this medicine to anyone who has chicken pox or symptoms of a virus or the flu, unless your doctor has told you to. If a child has behavior changes along with nausea and vomiting while using this medicine, call the doctor right away.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash.
• Bloody or black, tarry stools.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Flu-like symptoms.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Problems with vision, speech, or walking.
• Rapid weight gain.
• Severe pain in your upper stomach.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Skin rash or blisters with fever.
• Sudden or severe headache.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vomiting blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, or upset stomach.
• Loss of appetite.
• Mild nausea or stomach pain.
• New or worse pain in your joints or muscles.
• Problems with your vision.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088